Using folinic acid to reduce toxicity from pemetrexed in cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the hematological toxicity experienced by patients undergoing treatment with pemetrexed, comparing those who receive folinic acid as a rescue therapy to those who do not. The primary endpoint focuses on the difference in neutrophil counts between the two groups at days 8-10 post-administration of pemetrexed. Secondary endpoints include assessing the severity of neutropenia, plasma homocysteine levels, chemotherapy efficacy, and the incidence of treatment interruptions. The trial involves 50 patients with stage IV non-small cell lung cancer or mesothelioma, participating in a multi-center, open-label, randomized design over four treatment cycles.

Why it matters

Who can join: the full rules

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. ≥18 years old
2. Eligible for treatment with pemetrexed-based chemotherapy based on indication.
3. ECOG performance score of 0-2.
4. Subject is able and willing to sign the Informed Consent Form

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Contraindications for treatment with folinic acid in line with the SmPC.

   1. Hypersensitivity to the active substance or to any of the excipients.
   2. Anaemia caused by vitamin B12 deficiency.
2. The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.

Where it's running

• Amphia Hospital
  Breda, Noord Brabant, Netherlands Recruiting
• Albert Schweitzer Hospital
  Dordrecht, Zuid Holland, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Ramon Contrucci, MSc
• Email: rcontrucci@amphia.nl
• Phone: 0765954354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.